MoonLake Immunotherapeutics launches Phase 3 VELA program for sonelokimab in moderate-to-severe hidradenitis suppurativa

MoonLake Immunotherapeutics has initiated its Phase 3 VELA clinical program, screening the first patients in the U.S. to evaluate sonelokimab for moderate-to-severe hidradenitis suppurativa (HS). This global program will use an advanced clinical response measure, HiSCR75, as the primary endpoint, with results anticipated by mid-2025. The 52-week study will span multiple sites across the U.S. and Europe, building on the previous Phase 2 MIRA trial.

HS is a chronic inflammatory skin condition affecting up to 4.1% of the global population, characterized by painful lesions and significant tissue damage. Sonelokimab, a Nanobody®, targets the inflammation by inhibiting IL-17A and IL-17F dimers, aimed at penetrating inflamed tissues effectively.

The VELA program comprises two identical trials, VELA-1 and VELA-2, which will collectively enroll 800 patients. Each trial will compare a 120mg dose of sonelokimab to a placebo, with the primary endpoint assessed at week 16. From then on, all participants will receive the 120mg dose through week 52, followed by an open-label extension for up to two years. The design closely mirrors the Phase 2 MIRA trial, which had identified the optimal dosage for HS.

Kristian Reich, MoonLake's Chief Scientific Officer, emphasized the significance of using HiSCR75 as the primary endpoint and the anticipated progress in enrolling 800 patients. He noted that the program marks a significant milestone in developing advanced treatments for HS, an under-diagnosed and under-treated condition. Dr. Hadar Lev-Tov from the University of Miami highlighted the debilitating nature of HS and the urgent need for new treatment options, given the limited availability of FDA-approved biologics. He underscored the promising results of sonelokimab in inhibiting IL-17F and IL-17A, crucial for deep tissue inflammation.

Dr. Seth B. Forman, a Principal Investigator at CenExel-FCR, expressed his enthusiasm about participating in the VELA program. He pointed out the critical need for new treatments for HS, especially those achieving higher response thresholds like HiSCR75. He also referred to the valuable insights gained from the Phase 2 MIRA trial, which set the stage for more ambitious treatment goals.

The initiation of the VELA program follows the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and positive feedback from the EMA. Both regulatory bodies endorsed MoonLake's Phase 3 approach for HS. Sonelokimab is still under investigation and not yet approved for use in any indication.

The VELA program aims to enroll 800 patients in two double-blind, placebo-controlled trials, VELA-1 and VELA-2, to assess the efficacy and safety of sonelokimab. The primary endpoint is the HiSCR75, which measures a 75% reduction in abscesses and inflammatory nodules without an increase in other lesions. Secondary endpoints will include HiSCR50, changes in the International Hidradenitis Suppurativa Severity Score System (IHS4), and reductions in Dermatology Life Quality Index (DLQI), among others.

Sonelokimab is a humanized Nanobody® consisting of three VHH domains, designed to bind IL-17A and IL-17F with high affinity. This investigational drug is being assessed for both HS and psoriatic arthritis (PsA), with future trials planned for other dermatological and rheumatological conditions.

MoonLake Immunotherapeutics focuses on developing innovative treatments for inflammatory diseases, with sonelokimab being their lead candidate. Founded in 2021 and based in Zug, Switzerland, the company aims to address significant unmet needs in conditions like HS and PsA.